AbbVie’s 24-hour Parkinson’s therapy to roll out on NHS

AbbVie’s 24-hour Parkinson’s therapy to roll out on NHS

Around 1,000 people with Parkinson’s disease will be able to access treatment with AbbVie’s Produodopa, the first therapy that can be delivered by a 24-hour subcutaneous infusion pump, according to NHS England.

Produodopa (foslevodopa/foscarbidopa) can now be used only for patients in the later stages of Parkinson’s who have stopped responding to standard oral treatment and may have to take more than 20 tablets a day – or receive therapy via a feeding tube – to try to control symptoms.

The treatment takes the form of a small and portable infusion pump that delivers the active ingredients over a 24-hour period and can be refilled at home by patients or their carers. AbbVie also supplies the feeding tube product, called Duodopa (levodopa–carbidopa intestinal gel), which uses a percutaneous jejunostomy tube and requires a surgical procedure to install.

The steady delivery of the active ingredients overcomes the peaks and troughs in blood levels that can allow symptoms to break through between oral doses and also includes a boost function.

Produodopa is designed to replace the dopamine neurotransmitter that becomes deficient in Parkinson’s, leading to symptoms like tremor, stiffness, and slowness of movement, as well as mental health and cognitive problems.

It was recommended for NHS use by NICE last year and has now been formally commissioned by NHS England. NICE’s equivalent in Scotland, the SMC, is due to deliver a verdict on Produodopa next month.

In clinical trials, Produodopa achieved sustained improvements in ‘off’ time – when symptoms return between medication doses – as well as ‘on’ time when symptoms are controlled without dyskinesia (involuntary movements), and morning akinesia or 'off' time upon waking.

“This is great news for hundreds of patients who are living with an often difficult and debilitating condition,” said James Palmer, NHS England’s medical director for specialised services and a consultant neurosurgeon.

“This important therapy will now offer a vital new option on the NHS for those who aren’t suitable for other treatments, such as deep brain stimulation, and we hope it will help nearly a thousand patients to manage their symptoms more effectively and go about their day with a better quality of life.”

AbbVie’s chief commercial officer, Jeff Stewart, said on the company’s recent annual results call that Produodopa “represents a potentially transformative next-generation therapy for advanced Parkinson’s disease and a $1 billion-plus peak sales opportunity.”

Produodopa has been launched in Europe, but has been stalled in the US after the FDA sent AbbVie a complete response letter (CRL) last year. The company recently filed a response to the FDA and has said it expects US approval in the second quarter of this year.

It could also face competition from other subcutaneous infusion therapies coming through the industry pipeline, notably Mitsubishi Tanabe Pharma’s ND-0612 – a liquid fixed dose combination of levodopa and carbidopa administered through a patch-pump or belt pump – which generated positive phase 3 trials last year.